FDA 510(k)

點尖科學可卡因代謝物酵素免疫分析

K 號：K191638 · 2020-03-12

決定日期2020-03-12

產品代碼DIO

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決定相當於

器材摘要

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Medtest DX. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K191638. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Medtest DX. The 510(k) number is K191638.

When did Pointe Scientific Cocaine Metabolite Enzyme Immunoassay receive FDA 510(k) clearance?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay received FDA 510(k) clearance on 2020-03-12, under 510(k) number K191638.

Who is the listed applicant for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA 510(k) record lists Medtest DX as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is DIO.

其他以 Medtest DX 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K191296點尖科學肌酸酐激酶（CK）試劑組

相關器械（代碼：DIO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K213211卡羅來納液體化學公司可卡因及可卡因代謝物酶免疫測定（COCM）試驗系統Carolina Liquid Chemistries Corp.K211973DRI 可卡因代謝物測試Microgenics Corporation K181499DRI 可卡因代謝物測試Microgenics Corporation K170293Emit II Plus 可卡因代謝物測試Siemens Healthcare Diagnostics, Inc.K163570卡羅來納液體化學公司可卡因及可卡因代謝物測試系統（COCM）Carolina Liquid Chemistries Corporation K162395MP DOA-10面板測試杯，MP DOA-11面板測試杯Mp Biomedicals, LLC

官方來源

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